Identifying symptoms of premenstrual syndrome and premenstrual dysphoria
The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders
This study is trying to understand the symptoms of premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) in women to see how they differ and what factors might be involved.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00001177 on ClinicalTrials.gov |
What this trial studies
This study aims to identify and describe the symptoms associated with premenstrual syndrome (PMS) in women. Participants will undergo clinical interviews, self-rating scales, and evaluations of mood and endocrine function. A subgroup of women with severe PMS, known as Premenstrual Dysphoric Disorder (PMDD), will be invited to participate in additional studies focusing on endocrine changes, treatment evaluations, and genetic factors. The study also includes women with recurrent brief depression as a comparison group.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 50 who experience moderate to severe menstrually-related mood disturbances.
Not a fit: Patients who are pregnant or have irregular menstrual cycles may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and treatment options for women suffering from PMS and PMDD.
How similar studies have performed: Other studies have shown success in understanding and treating menstrually-related mood disorders, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: The subjects of this study will be women who meet the following criteria: * history within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a notable degree of subjective distress; * a 30% increase in mean negative mood ratings (relative to the range of the scale employed) in the premenstrual week compared with the week following the end of menses in at least two of three cycles; * age 18 to 50; * not pregnant and in good medical health; * regular menses. For subjects with recurrent brief depression: * dysphoric mood or loss of interest or pleasure; * duration less than two weeks; * four of the following symptoms: poor appetite or significant weight loss (when not dieting) or increased appetite or significant weight gain; insomnia or hypersomnia; psychomotor agitation or retardation; loss of interest or pleasure in usual activities, or decrease in sexual drive; loss of energy; fatigue; feelings of worthlessness, self-reproach, or excessive or inappropriate guilt; diminished ability to think or concentrate, slowed thinking, or indecisiveness; * impairment in usual occupational activities; * at least one-two episodes per month over one year. Age-matched women without mood and behavioral disorders will be recruited. EXCLUSION CRITERIA for all study participants: * Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder); * Current antidepressant therapy (since this is a screening protocol for subsequent treatment and physiologic evaluation studies in which participants must be untreated). Antidepressants will not be withheld from participants who need or want them; * Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups). * Pregnant or lactating women * Subjects who are unable to provide informed consent * NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Peter J Schmidt, M.D. — National Institute of Mental Health (NIMH)
- Study coordinator: Peter J Schmidt, M.D.
- Email: peterschmidt@mail.nih.gov
- Phone: (301) 496-6120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.